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首页> 外文期刊>Trials >The Pocket-4-Life project, bioavailability and beneficial properties of the bioactive compounds of espresso coffee and cocoa-based confectionery containing coffee: study protocol for a randomized cross-over trial
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The Pocket-4-Life project, bioavailability and beneficial properties of the bioactive compounds of espresso coffee and cocoa-based confectionery containing coffee: study protocol for a randomized cross-over trial

机译:Pocket-4-Life项目,浓缩咖啡和含咖啡的可可基糖果的生物活性化合物的生物利用度和有益特性:一项随机交叉试验的研究方案

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Coffee is an important source of bioactive compounds, including caffeine, phenolic compounds (mainly chlorogenic acids), trigonelline, and diterpenes. Several studies have highlighted the preventive effects of coffee consumption on major cardiometabolic diseases, but the impact of coffee dosage on markers of cardiometabolic risk is not well understood. Moreover, the pool of coffee-derived circulating metabolites and the contribution of each metabolite to disease prevention still need to be evaluated in real-life settings. The aim of this study will be to define the bioavailability and beneficial properties of coffee bioactive compounds on the basis of different levels of consumption, by using an innovative experimental design. The contribution of cocoa-based products containing coffee to the pool of circulating metabolites and their putative bioactivity will also be investigated. A three-arm, crossover, randomized trial will be conducted. Twenty-one volunteers will be randomly assigned to consume three treatments in a random order for 1?month: 1 cup of espresso coffee/day, 3 cups of espresso coffee/day, and 1 cup of espresso coffee plus 2 cocoa-based products containing coffee twice per day. The last day of each treatment, blood and urine samples will be collected at specific time points, up to 24?hours following the consumption of the first product. At the end of each treatment the same protocol will be repeated, switching the allocation group. Besides the bioavailability of the coffee/cocoa bioactive compounds, the effect of the coffee/cocoa consumption on several cardiometabolic risk factors (anthropometric measures, blood pressure, inflammatory markers, trimethylamine N-oxide, nitric oxide, blood lipids, fasting indices of glucose/insulin metabolism, DNA damage, eicosanoids, and nutri-metabolomics) will be investigated. Results will provide information on the bioavailability of the main groups of phytochemicals in coffee and on their modulation by the level of consumption. Findings will also show the circulating metabolites and their bioactivity when coffee consumption is substituted with the intake of cocoa-based products containing coffee. Finally, the effect of different levels of 1-month coffee consumption on cardiometabolic risk factors will be elucidated, likely providing additional insights on the role of coffee in the protection against chronic diseases. ClinicalTrials.gov, NCT03166540 . Registered on May 21, 2017.
机译:咖啡是重要的生物活性化合物的来源,包括咖啡因,酚类化合物(主要是绿原酸),松果碱和二萜。几项研究突出了咖啡摄入量对主要心脏代谢疾病的预防作用,但咖啡剂量对心脏代谢风险标志物的影响尚不十分清楚。此外,仍然需要在现实生活中评估咖啡衍生的循环代谢物库以及每种代谢物对疾病预防的贡献。这项研究的目的是通过使用创新的实验设计,根据不同的消费水平定义咖啡生物活性化合物的生物利用度和有益特性。还将研究含咖啡的可可基产品对循环代谢产物库及其假定生物活性的贡献。将进行三臂交叉的随机试验。将随机分配21名志愿者,以1个月的随机顺序服用三种疗法:每天1杯浓缩咖啡,每天3杯浓缩咖啡,1杯浓缩咖啡以及2种含可可粉的产品每天喝两次咖啡。每次治疗的最后一天,将在特定时间点(第一类产品食用后最多24小时)收集血液和尿液样本。每次治疗结束时,将重复相同的协议,切换分配组。除了咖啡/可可生物活性化合物的生物利用度之外,咖啡/可可摄入量还对几种心脏代谢风险因素(人体测量,血压,炎症标记,三甲胺N-氧化物,一氧化氮,血脂,空腹血糖/将研究胰岛素代谢,DNA损伤,类花生酸和营养代谢)。结果将提供有关咖啡中主要植物化学成分的生物利用度以及其对食用水平的调节的信息。研究结果还将显示当摄入的咖啡被摄入含咖啡的可可基产品所代替时,循环代谢物及其生物活性。最后,将阐明不同水平的1个月咖啡摄入量对心脏代谢危险因素的影响,可能会提供有关咖啡在预防慢性疾病中作用的更多见解。 ClinicalTrials.gov,NCT03166540。 2017年5月21日注册。

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